MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Application Program Problem (2880); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the reason for call was that they were really confused as one day (they believed it was yesterday morning) both the controller and the ins were charged to 100%; patient stated that they had the ins on all night and that it was unusual that the ins battery would be at 100% because usually the ins battery would be down to 40% after having the ins on overnight.The patient stated that they have to recharge the ins twice a day.Patient services (pss) asked the patient if the stimulation was on or off since the ins battery hadn't depleted; pss understood that the patient stated that they pushed the white button on the top of the controller and that the controller didn't say that stimulation was off, however they pressed the option to turn stimulation on to ensure that the stimulation was on.The patient stated that the stimulation went off once and that the ins hasn't been working really good because they will be getting an injection on (b)(6).When pss asked for the event date of when the ins started not working, the patient stated that they didn't know and that they had lost faith in the ins since their back hurts so bad and that it seems like nobody can adjust the ins so that the ins will work.The patient mentioned that they have a new manufacturer representative (rep) that will be present when they get the injection in their back who will try to reprogram the ins.The patient stated that they didn't understand why they need injections in their back when they have the ins that they should be able to use.The patient stated that the trial ins worked wonderful and that they could walk straight up and down.The patient stated that the ins never worked right.

Event Description

The patient reported again having so much pain.The pain has been there all the time, forever.The ins has not worked from the time it was implanted.Pt said it was so hard to be in pain.Pt reported today when trying to change settings so that they could get some relief pt gets settings not available since last month.Pt tried it on the call and was able to adjust in group b this time.Pt said one time last week pt went to group b and it went off.Pt first said 2021 but pt also said they had been in pain since implanted.Pt mentioned they had appointments with other hcps next week.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12307930
• MDR Text Key: 266035127
• Report Number: 3004209178-2021-12248
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female